A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections

• Status: Recruiting
• Trial end date: 2023-12-26
• Target enrollment: 0
• Participant gender: All

Summary

The main aim of the study is to investigate the plasma pharmacokinetics (PK) and safety of intravenous (IV) administration of a single dose of 600 mg RO7223280 in critically ill participants with bacterial infections.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Illness requiring treatment in an intensive care unit (ICU) at the time of enrolment

• Ongoing clinical syndrome meeting at least one of the following criteria:

1. HABP: bacterial pneumonia diagnosed after more than 48 hours of hospitalization or within 7 days after a hospital discharge

2. Ventilator-associated bacterial pneumonia (VABP): bacterial pneumonia diagnosed after more than 48 hours of mechanical ventilation or within 72 hours after weaning

3. Bacteremia confirmed by the presence of a bacterial pathogen in a blood culture drawn within 7 days prior to dosing and with the defined focus of infection.

Exclusion Criteria:

• Ongoing documented catheter-related bacteraemia as the sole ongoing infection

• Major surgery within 48 hours prior to dosing or major surgery expected within 48 hours after the start of the infusion

• Known chronic severe hepatic impairment (Child-Pugh class C). Note: acute severe hepatic impairment is not exclusionary